Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc., 23067 [2017-10238]

Download as PDF 23067 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices [Docket No. DEA–392] Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on December 2, 2016, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237 applied to be registered as a bulk manufacturer of gamma hydroxybutyric acid (2010) a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance for product development. Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on March 21, 2017, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, Texas 78665 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... I I The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for these drug codes is authorized for this registration. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10230 Filed 5–18–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [FR Doc. 2017–10238 Filed 5–18–17; 8:45 am] ACTION: Notice of application. BILLING CODE 4410–09–P Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before July 18, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW 8701 DATES: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before July 18, 2017. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on March 3, 2017, Eli-Elsohly Laboratories, Mahmoud A. Elsohly Ph. D., 5 Industrial Park Drive, Oxford, Mississippi 38655 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories ACTION: Notice of application. asabaliauskas on DSK3SPTVN1PROD with NOTICES Controlled substance Drug code Marihuana Extract ........................................................................................................................................................... Marihuana ........................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................... Dihydromorphine ............................................................................................................................................................. Amphetamine ................................................................................................................................................................... Methamphetamine ........................................................................................................................................................... Cocaine ............................................................................................................................................................................ Codeine ........................................................................................................................................................................... Dihydrocodeine ................................................................................................................................................................ Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Ecgonine .......................................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Morphine .......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00115 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 7350 7360 7370 9145 1100 1105 9041 9050 9120 9143 9150 9180 9193 9300 9333 Schedule I I I I II II II II II II II II II II II

Agencies

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Page 23067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10238]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Patheon 
Pharmaceuticals, Inc.

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic class, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.33(a) on or before July 18, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW 8701 
Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on 
December 2, 2016, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith 
Road, Cincinnati, Ohio 45237 applied to be registered as a bulk 
manufacturer of gamma hydroxybutyric acid (2010) a basic class of 
controlled substance listed in schedule I.
    The company plans to manufacture the listed controlled substance 
for product development.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10238 Filed 5-18-17; 8:45 am]
BILLING CODE 4410-09-P